1Department of Family Medicine, Obesity, Nutrition and Metabolism Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Republic of Korea2Department of Medical Education, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea3Department of Biomedical Informatics, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea4Center for Anti-Aging Industry, Pusan National University, Busan 47046, Republic of Korea5Bio-Port Korea INC, Marine Bio-Industry Development Center, Busan 46048, Republic of Korea

Abstract

Ulmus macrocarpa extract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration of Ulmus macrocarpa Hance extract (UME) on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks. Mean fluorescence intensity (MFI) of tumor necrotic factor-α increased only in the UME group at 1 week . The MFI of interleukin-2 decreased less significantly in the UME group than in the placebo group at 1 week . However, unfortunately, at 4 weeks, no intergroup differences were detected in MFIs of cytokine. In conclusion, administration of UME for 1 week increased serum TNF-α and sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people. However, additional studies are needed to confirm the results of this first-stage study and further trials are required to decide on optimal dosage and duration of administration. This trial is registered with ClinicalTrials.gov Identifier: NCT02414412.